FDA
commissioner to stand down after six years: sources
Send a link to a friend
[February 05, 2015]
By Toni Clarke
WASHINGTON (Reuters) - Dr. Margaret
Hamburg, commissioner of the U.S. Food and Drug Administration (FDA),
who for almost six years has overseen public health initiatives ranging
from tobacco control and food safety to personalized medicine, disease
control and drug approvals, is stepping down, according to a person
briefed on the matter.
|
The White House is expected to announce Hamburg's resignation
later on Friday, the person said. FDA spokeswoman Stephanie Yao
declined to comment.
Hamburg, 59, is one of the longest-serving FDA commissioners in the
modern era. She was nominated by President Barack Obama and
confirmed by the U.S. Senate in May 2009 and last year was named the
world's 51st most powerful woman by Forbes.
Dr. Stephen Ostroff, the FDA's chief scientist, will fill Hamburg's
position until a new commissioner is named, said a second person
familiar with the matter.
Late last month, the agency named Dr. Robert Califf, a prominent
cardiologist and researcher from Duke University, to oversee its
drug, medical device and tobacco policy. Califf is viewed by many as
a potential successor to Hamburg.
A long-time public health official with extensive experience
fighting AIDS and tuberculosis, Hamburg, who graduated from Harvard
Medical School, previously served at the National Institutes of
Health before becoming New York City's health commissioner. She was
not available for comment.
![](http://archives.lincolndailynews.com/2015/Feb/05/images/ads/current/humanesociety_sda022411.png) Her resignation comes as the FDA prepares for what could be a
significant transformation, spurred on the one hand by initiatives
in Congress to further speed new drug development, and on the other
by food safety advocates, backed by the President, who would like to
see the creation of a separate agency combining the food safety
functions of the FDA and the U.S. Department of Agriculture.
MORE ENGAGEMENT
Under Hamburg's leadership the FDA, which oversees products
representing more than 20 cents of every dollar spent by U.S.
consumers, has proposed measures to improve nutrition by limiting
dangerous trans-fats in food and requiring restaurants to post
calorie counts on menus. It has also beefed up inspections of food
and drugs from overseas, and increased patient engagement in the
drug development process.
The agency has introduced multiple measures to speed the development
and review of new drugs. In 2014, the FDA approved 51 new therapies,
the most in almost 20 years. In a blog post on Wednesday, Hamburg
called the achievement "a testament ... to FDA's innovative
approaches to help expedite development and review of medical
products that target unmet medical needs."
[to top of second column] |
![](http://archives.lincolndailynews.com/2015/Feb/05/images/ads/current/graue_2014_Sonic_010615.png)
During her tenure the FDA has confronted major public health issues,
including the rise of antibiotic-resistant bacteria, the abuse of
opioid painkillers, the emergence of electronic cigarettes and the
outbreak of Ebola and other infectious diseases.
Her ride has not always been smooth. She faced hostile questioning
by Republicans in Congress following a fungal meningitis outbreak in
2012 that killed dozens and sickened hundreds more. And she has been
caught up in some controversial political battles.
In 2011, then Health and Human Services Secretary Kathleen Sebelius
overruled the FDA's decision to allow an emergency contraceptive
known as Plan B to be sold over the counter to young teenagers.
Hamburg insisted Plan B was safe for use, and it was eventually
approved two years later.
Hamburg was never a crusading commissioner in the way of one of her
predecessors, Dr. David Kessler, who fought to bring tobacco under
FDA regulation. But she has made her mark on multiple issues,
including the use of targeted therapy to tailor medicines to an
individual's genetic makeup. The FDA gained regulatory authority
over tobacco products for the first time on her watch, in 2009.
Hamburg comes from a distinguished medical family. Her mother was
the first African-American woman to attend Vassar College and to
earn a degree from Yale University School of Medicine.
(Editing by Ian Geoghegan)
[© 2015 Thomson Reuters. All rights
reserved.]
Copyright 2015 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
![](http://archives.lincolndailynews.com/2015/Feb/05/images/ads/current/ccaonline_lda050208.png) |